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Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint (D-COG)

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ClinicalTrials.gov Identifier: NCT02185222
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Tracking Information
First Submitted Date  ICMJE June 30, 2014
First Posted Date  ICMJE July 9, 2014
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE October 23, 2014
Actual Primary Completion Date October 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2014)
Changes from baseline memory functions measured by the score of the total recall test from Free and Cued Selective Recall Reminding Test (Rappel Libre / Rappel Indicé 16 items : RL/RI 16) at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
The score of the total recall test from Free and Cued Selective Recall Reminding Test (RL/RI 16) is recommended by a European Task Force consensus.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2014)
  • Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years [ Time Frame: Baseline (inclusion), one year and two years ]
  • Evolution of anaemia evaluated by red blood cells count [ Time Frame: Baseline (pre-inclusion), one year and two years ]
  • Evolution of plasma calcium and albumin concentration [ Time Frame: Baseline (pre-inclusion), 45 days, one year and two years ]
  • Evolution of urinary calcium and creatinine concentration [ Time Frame: 45 days, one year and two years ]
  • All adverse events [ Time Frame: Up to two years ]
  • Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance [ Time Frame: Baseline (pre-inclusion), one year and two years ]
  • Changes from baseline global efficiency measured by the Mini Mental State Examination at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
  • Changes from baseline global efficiency measured by the Montreal Cognitive Assessment at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
  • Changes from baseline instrumental activity of daily living measured by 8 items at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
  • Changes from baseline language measured by the "test de denomination orale d'images" (DO-80) at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
  • Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48) [ Time Frame: Baseline at inclusion ]
  • Changes from baseline executive functions measured by the stroop test at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
  • Changes from baseline executive functions measured by the verbal fluency at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
  • Changes from baseline executive functions measured by the Trail Making Test part B at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
  • Changes from baseline attention and speed processing measured by the Trail Making Test part A at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
  • Changes from baseline attention and speed processing measured by the Digit symbol test at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
  • Changes from baseline visuospatial study measured by the Rey figure (copy) at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
  • Changes from baseline praxis at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
    Production of symbolic gesture, imitation utilization gesture, non sense gesture imitation
  • Changes from baseline depressive symptoms measured by the Montgomery and Asberg Depression Rating Scale at one year and at two years [ Time Frame: Baseline (at inclusion), one year and two years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
Official Title  ICMJE Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
Brief Summary As recommended allowance of oral vitamine D are unable to ensure the recommended serum concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3 higher than the recommended allowance may slow the cognitive decline of patients with a memory complaint.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Memory Disorders
  • Age-Related Cognitive Decline
Intervention  ICMJE
  • Drug: Cholecalciferol 100 000 UI
    Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
    Other Name: Uvedose
  • Drug: Placebo
    Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
Study Arms  ICMJE
  • Experimental: Cholecalciferol 100 000 UI (Unité Internationale)
    Oral solution in single-dose : 100 000 UI per month
    Intervention: Drug: Cholecalciferol 100 000 UI
  • Placebo Comparator: Placebo
    Oral solution in single-dose per month
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2017)
68
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2014)
350
Actual Study Completion Date  ICMJE October 10, 2018
Actual Primary Completion Date October 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Pre-Inclusion Criteria :

  • Patients aged 60 years or older,
  • Who report to a memory centre with symptoms of memory complaint,
  • Having a Mini-Mental State Examination (MMSE) score strictly > the 5th percentile for sociocultural level of the patient (GRECO standards for elderly patients),
  • Having visual, hearing abilities (authorized equipment) and an oral or written expression sufficient for the suitable realization of the tests,
  • Who accept participation in the study and are able to sign the informed consent of the - Affiliated to the French social security system.

Inclusion Criteria:

  • Insufficient 25 OH D serum level : 25 OH D < 50 nmol/L (20 ng/ml),
  • Normal corrected plasma calcium concentration,
  • Normal kidney function (cockcroft > 30 mL/mn)

Exclusion Criteria:

  • Alzheimer's disease or other dementia,
  • Parkinson's disease treated,
  • Epilepsy treated,
  • Huntington's disease,
  • Brain tumor,
  • History of a progressive disease which may have consequences for the central nervous system (blood pressure, higher or equal to 180/100 mmHg, chronic pulmonary disease with hypoxia; cerebrovascular accident of less than 3 months, cranial traumatism with persistent neurologic deficit, subdural hematoma, brain surgery),
  • Antecedent of alcoholism or chronic drug-addiction with an obvious or documented consequence on cognition,
  • Severe depression : score Montgomery Asberg Depression Rating Scale (MADRS) > 18,
  • Psychotropic drug therapy (at the discretion of the clinician),
  • Hypercalcaemia or treatment for a hypercalcaemia,
  • Known hypersensitivity to the vitamin D,
  • Granulomatous disease,
  • Treatment of vit D at doses higher than the current recommendations,
  • History of calcium urinary lithiasis of less than 1 year,
  • Nonsteroidal antiinflammatory drug (NSAID) chronic treatment,
  • Severe medical or surgical affection of less than 3 months,
  • Unstable health, severe hepatic or renal deficiency,
  • Deprivation of liberty, under judicial protection,
  • Institutionalization (EHPAD),
  • Illiteracy,
  • Participation in another biomedical research. A diagnosis of MCI (Mild Cognitive Impairment) of less than 6 months is not a criterion of non-inclusion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02185222
Other Study ID Numbers  ICMJE SERC12-TC / D-COG
2013-005110-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Tours
Study Sponsor  ICMJE University Hospital, Tours
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fanny HENNEKINE, PH CHRU TOURS - Hôpital Bretonneau
PRS Account University Hospital, Tours
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP